510(k) K012978 ยท LCD Enzyme Immunoassay, Gentamicin
RANDOX GENTAMICIN
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Sep 18, 2001 |
| Received | Jul 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012978
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.